Policy for Reporting Clinical Study Serious Adverse Events

National Heart, Lung, and Blood Institute
National Institutes of Health

Effective Date: May 1, 2002

Serious adverse events are currently reported by the investigator to the Institutional Review Board (IRB), Data and Safety Monitoring Board (DSMB), Food and Drug Administration (FDA), and to the Office of Biotechnology Activities (OBA, for gene therapy), as appropriate.  Because the National Heart, Lung, and Blood Institute (NHLBI) is especially concerned about the safety of patients in clinical studies that it supports, it is instituting the additional reporting requirements described in this document.

Policy

All investigators conducting clinical studies supported by the NHLBI must report expected and unexpected serious adverse events to the NHLBI, as described below. Serious adverse events that will be reported to the investigator's IRB and to the study DSMB as applicable, must be specifically defined for each protocol and the definition approved by the IRB.  

For studies with a Data Coordinating Center, the investigator must forward copies of all reports of serious adverse events that are unexpected when they are submitted to the IRB, DSMB, FDA, or OBA.

For studies without a Data Coordinating Center, the investigator must forward copies of all reports of serious adverse events (expected and unexpected) when they are submitted to the IRB, DSMB, FDA, or OBA.

Expedited reporting is required for serious adverse events that are unexpected.

• If the unexpected events are life-threatening or fatal, they should be reported within 7 calendar days.  
• All other serious adverse events that are unexpected should be reported within 15 calendar days.

Copies of reports are sent to the NHLBI Program or Project Officer responsible for the study.

Definitions

An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.

Serious Adverse Events include those which:

• Are fatal or life threatening;
  
  
• Result in significant or persistent disability;
  
  
• Require or prolong hospitalization;
  
  
• Result in a congenital anomaly/birth defect;
  
  
• Represent other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators.

Unexpected Serious Adverse Events are those that have not been described in the:

• Package insert for a given drug or investigator's brochure (for FDA investigational agents);
  
  
• Protocol; or
  
  
• Informed consent document.

Contact

For additional information contact the NHLBI Program or Project Official associated with your study.